510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Aptus Foot System

K091479510(k) TraditionalCleared Jul 13, 200955-day reviewClass II21 CFR 888.3030Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medartis AG · HRS Plate, Fixation, Bone

Cleared on Jul 13, 2009 after a 55-day review. The FDA summary names no predicate by number. 51 later devices descend from it. It has been recalled 2 times.

Decided
Jul 13, 2009
Review
55 days
Class
Class II
Product code
HRS
Recalls
2
Predicates
0

51 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2025: 5 descendants cleared2011: 2 descendants cleared2020: 6 descendants cleared2024: 8 descendants cleared2017: 4 descendants cleared2023: 10 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2026: 8 descendants cleared20052010201520202025
  1. This deviceK091479 Aptus Foot SystemMedartis AG · 2009
  2. Descendant · cites it directly · 25 of its ownK110908 Aptus Foot 3.5 SystemMedartis AG · 2011
  3. Descendant · cites it directly · 22 of its ownK142581 APTUS Foot SystemMedartis AG · 2015
  4. Descendant · cites it directly · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
  5. Descendant · cites it directly · 11 of its ownK193633 APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020
  6. Descendant · 2 generations on · 11 of its ownK193222 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2011: 22015: 22017: 42018: 12019: 32020: 62021: 22023: 102024: 82025: 52026: 8
2011high 10 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 51 · See all
  • K110908Aptus Foot 3.5 SystemMedartis AG · 2011 · cites it directly25descendants
  • K142581APTUS Foot SystemMedartis AG · 2015 · cites it directly22descendants
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · cites it directly19descendants
  • K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG · 2020 · cites it directly11descendants
  • K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2020 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K091479Aptus Foot SystemMedartis AG2009—
+1K110908Aptus Foot 3.5 SystemMedartis AG2011—
+1K142581APTUS Foot SystemMedartis AG2015—
+1K162674BioPro Foot Plating SystemsBiopro, Inc.2017—
+1K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG2020—
+2K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201520
201740
201810
201930
202060
202120
2023100
202480
202550
202680
FIG. 1 — Lineage of K091479, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (51)

See all 51

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110908Aptus Foot 3.5 SystemMedartis AG201125
K142581APTUS Foot SystemMedartis AG201522
K162674BioPro Foot Plating SystemsBiopro, Inc.201719
K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG202011
K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209
K112560Aptus (R) Distal Humerus SystemMedartis AG20118
K161894SurgTech Trauma SystemSurgtech, Inc.20173
K243469SignexOsteonic Co., Ltd.20250
K232105APTUS Foot System 2.8-3.5Medartis AG20240

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2026Class IIZ-1550-2026Labeling mix-upsMix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Apr 12, 2024Class IIZ-1821-2024Process controlScrew is 16mm long instead of 22mm long.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K110908 (Medartis AG, 2011) has gone furthest, with 25 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

Indications for use as stated in the FDA summary.

More from Medartis AG

42 FDA decisions under this applicant name. See the company

  • K260761APTUS Clavicle System 2.8Medartis AG · 2026
  • K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
  • K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
  • K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K091479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091479: Aptus Foot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091479

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026